Senior Clinical Scientist (Pharmacologist) - Pharmacology, US REMOTE Based
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Senior Clinical Scientist (Pharmacologist) - Pharmacology, US REMOTE Based
Join to apply for the Senior Clinical Scientist (Pharmacologist) - Pharmacology, US REMOTE Based role at Fortrea
Fortrea is seeking a Clinical Scientist (CS) focused on pharmacology to provide ongoing in-depth analysis and scientific input into development and execution of protocols and clinical development plans by working with the medical/scientific/regulatory team to creatively solve a wide range of medical/scientific/clinical/regulatory problems. The CS works with the Medical Monitor/study support on a protocol/program basis for early clinical trials.
What To Expect
- Provides ongoing in-depth analysis and scientific input into development and execution of protocols and clinical development plans.
- Remains current on issues in scientific expertise through active, ongoing participation in relevant scientific meetings and courses.
- Works with the medical/scientific/regulatory team to creatively solve a wide range of medical/scientific/clinical/regulatory problems.
- Provides writing, review, editing and QC of applicable project documents, including: proposals, synopses, protocols, amendments, reports, narratives, investigator brochures, informed consent forms, manuscripts, clinical development plans and analysis plans that meet scientific and regulatory standards, as applicable.
- Provides scientific and logistical rationale/input for including biomarkers or other lab markers in Proof-of-Concept (POC) studies.
- Interacts with Fortrea Early Phase Development Solutions (EPDS) and participates on Molecule Development Teams as the early clinical representative.
- Oversee or assist in the planning and conduct of DSMB, Safety Review Committee, Cohort Review, Dose Escalation, Data Review or other medical-related study meetings.
- Writes draft Medical Responsibility, Safety and other related plans and facilitates their review and approval by Medical Monitor, Project Managers and Sponsors, as needed.
- Attends Kick-off Meetings and SIVs/Investigator Meetings. Supports training in key medical/scientific areas.
- Attends Team Meetings. Ensures that any medical/safety issues discussed at the meeting are resolved by the Medical Monitor in a timely manner.
- Serves as a resource for the Medical Monitor by tracking and reviewing ongoing studyspecific safety data (e.g., adverse events, vitals, ECGs and safety lab results) to identify safety trends.
- Acts as a liaison between the Medical Monitor in all communications between study sties, Fortrea project staff and Sponsors regarding protocol or other study-related questions, including documenting, tracking and follow-up on all issues.
- Supports CPS Medical Monitors in tracking and documenting any Inclusion/Exclusion criteria or protocol-related questions and answers.
- Supports the Medical Monitor in the review and interpretation of data from clinical studies, including data files, tables, figures and listings.
- Ensures SAEs are handled appropriately and in a timely manner. Supports Medical Monitor and Project Teams by reviewing SAE reports for completeness. Interacts with Fortrea/Sponsor/3rd Party safety groups, as needed to support SAE management.
- Participates in and/or leads process improvement initiatives such as establishing and improving document standards, documentation processes, developing new procedures, process mapping and SOP review/revision.
- All other duties as needed or assigned.
Qualifications (Minimum Required)
- Bachelor’s degree in an applicable scientific field, plus 10-12 years of relevant experience; or a Master’s degree in an applicable scientific field, plus 4-6 years of relevant experience; or a PhD degree in an applicable scientific field.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Knowledge of GCPs and regulatory agency guidelines.
- Ability to conduct limited review of related literature and references to obtain the required information and subsequently apply it.
- Skilled in data interpretation.
- Fluent in English, both written and verbal.
Experience (Minimum Required)
- Up to 10-15 years of relevant experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, or data management).
- Additional experience may be substituted for education requirements.
Physical Demands/Work Environment
- Office working conditions.
- Overtime and weekend work as required.
- Travel Requirements less than 10% Regional.
Position is based remote in US
This position is not eligible for sponsorship
Pay Range: $110,000-$130,000 USD base annual salary;
Benefits:
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.
The application deadline is July 1, 2025.
Learn more about our EEO & Accommodations request here.
Seniority level
Seniority level
Mid-Senior level
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Research, Analyst, and Information Technology
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